Older AdultAGE-BOTNCT07498530
Virtual Assistant for Exercise Adherence in Older ADULTS
A study testing Exercise program in people with Older Adult and Exercise, run by University of Valencia at 1 site in Spain.
Trial summary
This study will evaluate the effectiveness of a virtual assistant-guided exercise program to improve adherence in older adults. In a nonrandomized controlled clinical trial, the experimental group will complete a 12-week, home-based program (60-minute sessions, 3 times per week) supported by a virtual assistant (BOT). Read more about this study
- Who is it for?
- Ages 59 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adult, Exercise, Adherence
- What is being tested?
- Exercise program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 59 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 60 years or older.
- Community-dwelling individuals capable of participating in an exercise program.
- Ability to complete 60-minute exercise sessions, three times per week during the 12-week intervention.
- Experimental group (BOT Group): Participants willing to use a smartphone/tablet and interact with the virtual assistant.
- Control group (Municipal Exercise Group): Individuals already enrolled in the municipal program Enguera se saludable.
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Medical contraindications to physical exercise, as determined by clinical judgment (e.g., uncontrolled cardiovascular, respiratory, or metabolic conditions).
- Severe cognitive impairment or neurological conditions that limit the ability to follow instructions or safely perform the exercise program.
- Severe mobility limitations preventing participation in structured exercise (e.g., inability to walk independently with or without aid).
- Acute musculoskeletal injuries or recent surgeries that contraindicate exercise participation.
- Individuals currently participating in another structured exercise program that would interfere with the study interventions (other than Enguera se saludable for the control group).
- Inability or unwillingness to comply with the requirements of the study (frequency, duration, assessments).
- For the BOT group: lack of access to a device compatible with the virtual assistant or inability/unwillingness to use it.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Carmen García Gomariz
Valencia, 46010
CARMEN, 963219340, Carmen.garcia-gomariz@uv.es
About this study
Official title: Application of a Virtual Assistant to Enhance Exercise Adherence in Older Adults
This study will evaluate the effectiveness of a virtual assistant-guided exercise program to improve adherence in older adults. In a nonrandomized controlled clinical trial, the experimental group will complete a 12-week, home-based program (60-minute sessions, 3 times per week) supported by a virtual assistant (BOT). The control group will comprise community-dwelling older adults already engaged in the municipal program Enguera se saludable, which delivers an in-person exercise program of comparable frequency and duration. The primary outcome is exercise adherence, defined as the proportion of prescribed sessions completed. Secondary outcomes include muscle strength, balance, functional capacity, health-related quality of life, and the user experience and usability of the virtual assistant.
Read the detailed description
The objective of this study is to determine whether a virtual assistant-controlled, home-based exercise program can improve adherence to therapeutic exercise among older adults, compared with a conventional municipal program of similar dosage. Although exercise is effective for preserving function and quality of life during aging, adherence remains suboptimal. Virtual assistants may offer a scalable and acceptable solution to support sustained participation.
The study will employ a nonrandomized controlled clinical trial (quasi-experimental design) involving community-dwelling adults aged ≥60 years. Participants will be allocated to groups based on program pathway:
Experimental group (Virtual Assistant/BOT): a structured home-based exercise program (60 minutes per session, 3 sessions per week for 12 weeks), guided and monitored by a virtual assistant (BOT), including automated session delivery, reminders, and adherence tracking.
Control group (Municipal program): older adults already participating in Enguera se saludable, an onsite, instructor-led municipal program with equivalent frequency and duration (60 minutes, 3 times per week for 12 weeks). Attendance records from the municipal program will quantify adherence.
The primary outcome is exercise adherence, defined as the proportion of prescribed sessions completed during the 12-week period, with predefined adherence thresholds (e.g., ≥75% of sessions completed). Secondary outcomes include changes in muscle strength, balance, functional performance, and health-related quality of life. Additional measures will include user perceptions, usability, and satisfaction with the virtual assistant to evaluate acceptability and feasibility.
Given the nonrandomized design and the pre-existing enrollment of the control group, the study will incorporate the following methodological safeguards:
Baseline demographic and clinical characteristics (e.g., age, sex, comorbidities, prior activity level) will be comprehensively documented.
Baseline imbalances will be controlled through statistical adjustment (e.g., covariate adjustment, propensity score procedures, and sensitivity analyses) to reduce selection bias and confounding.
Exercise dosage (frequency, duration, and intervention length) will be matched across groups, or, when small discrepancies arise, dosage will be included as a covariate in the analyses.
This study is expected to contribute evidence regarding whether a virtual assistant-based exercise program represents a viable, effective, and acceptable alternative to conventional program delivery models for promoting active and healthy aging in community-dwelling older adults.
- Conditions
- Older Adult, Exercise, Adherence, Prevention, New Technologies
- Being tested
- Exercise program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programProcedure or surgery
BOT Group: Home-based exercise program delivered through a virtual assistant for 12 weeks (60 minutes, three times per week), including guided instructions and adherence monitoring.
Enguera Exercise Group: Face-to-face, instructor-led exercise sessions from the Enguera se saludable program, with the same frequency and duration (60 minutes, three times per week for 12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Bot Group | Experimental | Participants in this group will complete a 12-week home-based exercise program delivered and monitored by a virtual assistant (BOT). The program consists of 60-minute sessions, three times per week, including guided instructions, automated reminders, and adherence tracking. The BOT provides real-time session support and records participation throughout the intervention. Receives: Procedure: Exercise program |
| Enguera program Group | Active comparator | Participants in this group are individuals already enrolled in the municipal program "Enguera se saludable", which offers a face-to-face, instructor-led exercise program of the same duration and frequency (60 minutes, three times per week for 12 weeks). Attendance is recorded routinely by program instructors and will be used to assess adherence. Receives: Procedure: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Adherence (% of prescribed sessions completed)
Exercise adherence will be defined as the percentage of prescribed exercise sessions completed during the 12-week intervention. A single adherence value will be calculated for each participant as:
\text{Adherence (%) = (Sessions completed / Sessions prescribed) × 100}
Measurement method:
Virtual Assistant/BOT Group: Adherence will be recorded automatically by the virtual assistant (BOT), which logs session completion in real time.
Municipal Exercise Group: Adherence will be calculated from attendance records routinely collected in the Enguera se saludable municipal program, using the same formula (completed / prescribed × 100).
Although adherence is obtained from different data sources, the measurement itself is identical in both groups, expressed as a percentage (%).
Measured: End of the 12-week intervention.
Secondary outcomes (4)
Physical performance assessed by the Short Physical Performance Battery (SPPB)
Lower-limb functional performance will be assessed using the Short Physical Performance Battery (SPPB), a validated instrument for older adults. The SPPB includes three components: balance tests, gait speed, and the 5-times sit-to-stand test. Each component is scored from 0 to 4, yielding a total score from 0 to 12, with higher scores indicating better physical performance.
Unit of measurement:
SPPB total score (0-12 points).
Measured: Baseline and 12 weeks.
Accelerometry-Based Physical Activity (Moderate-to-Vigorous Activity Levels)
Moderate-to-vigorous physical activity (MVPA) will be quantified using a wrist- or hip-worn triaxial accelerometer. MVPA will be calculated according to established cut-points for older adults, expressed as minutes per day accumulated at moderate or vigorous intensity. Devices will be worn during the monitoring period, and raw acceleration data will be processed using standardized algorithms to derive daily MVPA time. A single MVPA value will be generated for each assessment period.
Unit of measurement:
Minutes/day of MVPA (moderate-to-vigorous physical activity).
Measured: Baseline and 12 weeks
Risk of falls measured by the FallSkip® system (Fall Risk Index, 0-100)
Risk of falls will be assessed using the FallSkip® system, an instrumented device that evaluates fall risk in older adults through a standardized functional protocol. The device records parameters such as reaction time, postural stability, gait acceleration/deceleration patterns, and sit-to-stand performance. These variables are integrated automatically by the device software to generate a Fall Risk Index on a 0-100 scale, with higher values indicating greater risk of falls. A single Fall Risk Index score will be obtained for each participant at every assessment time point.
Unit of measurement:
FallSkip® Fall Risk Index (0-100 points).
Measured: Baseline and 12 weeks
User experience and usability of the virtual assistant measured with a Visual Analog Scale (VAS)
User experience and usability of the virtual assistant (BOT) will be evaluated using a Visual Analog Scale (VAS), an anchored numerical scale ranging from 0 to 10, in which 0 represents the worst possible user experience/usability and 10 represents the best possible user experience/usability. Participants will rate their overall experience and perceived usability of the virtual assistant on this single-item scale. A single VAS score will be obtained for each assessment period.
Unit of measurement:
Score on the Visual Analog Scale (0-10), where higher scores indicate better user experience/usability.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Feb 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nonrandomized controlled clinical trial comparing a virtual assistant-guided home-based exercise program with the existing municipal program Enguera se saludable to evaluate adherence and health outcomes in older adults.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Generalitat Valenciana
- Responsible party
- Principal investigator, CARMEN GARCÍA GOMARIZ, University of Valencia
- Investigators
- CARMEN GARCÍA GOMARIZ, Phd, Principal investigator, UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498530
- Sponsor's protocol ID
- ESS_BOT01
- Acronym
- AGE-BOT
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Virtual Assistant to Enhance Exercise Adherence in Older Adults
- ClinicalTrials.gov ID
- NCT07498530
- Acronym / sponsor ID
- AGE-BOT / ESS_BOT01
- Conditions
- Older Adult, Exercise, Adherence, Prevention, New Technologies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Generalitat Valenciana
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of a virtual assistant-guided exercise program to improve adherence in older adults. In a nonrandomized controlled clinical trial, the experimental group will complete a 12-week, home-based program (60-minute sessions, 3 times per week) supported by a virtual assistant (BOT). The control group will comprise community-dwelling older adults already engaged in the municipal program Enguera se saludable, which delivers an in-person exercise program of comparable frequency and duration. The primary outcome is exercise adherence, defined as the proportion of prescribed sessions completed. Secondary outcomes include muscle strength, balance, functional capacity, health-related quality of life, and the user experience and usability of the virtual assistant.
Detailed description
The objective of this study is to determine whether a virtual assistant-controlled, home-based exercise program can improve adherence to therapeutic exercise among older adults, compared with a conventional municipal program of similar dosage. Although exercise is effective for preserving function and quality of life during aging, adherence remains suboptimal. Virtual assistants may offer a scalable and acceptable solution to support sustained participation.
The study will employ a nonrandomized controlled clinical trial (quasi-experimental design) involving community-dwelling adults aged ≥60 years. Participants will be allocated to groups based on program pathway:
Experimental group (Virtual Assistant/BOT): a structured home-based exercise program (60 minutes per session, 3 sessions per week for 12 weeks), guided and monitored by a virtual assistant (BOT), including automated session delivery, reminders, and adherence tracking.
Control group (Municipal program): older adults already participating in Enguera se saludable, an onsite, instructor-led municipal program with equivalent frequency and duration (60 minutes, 3 times per week for 12 weeks). Attendance records from the municipal program will quantify adherence.
The primary outcome is exercise adherence, defined as the proportion of prescribed sessions completed during the 12-week period, with predefined adherence thresholds (e.g., ≥75% of sessions completed). Secondary outcomes include changes in muscle strength, balance, functional performance, and health-related quality of life. Additional measures will include user perceptions, usability, and satisfaction with the virtual assistant to evaluate acceptability and feasibility.
Given the nonrandomized design and the pre-existing enrollment of the control group, the study will incorporate the following methodological safeguards:
Baseline demographic and clinical characteristics (e.g., age, sex, comorbidities, prior activity level) will be comprehensively documented.
Baseline imbalances will be controlled through statistical adjustment (e.g., covariate adjustment, propensity score procedures, and sensitivity analyses) to reduce selection bias and confounding.
Exercise dosage (frequency, duration, and intervention length) will be matched across groups, or, when small discrepancies arise, dosage will be included as a covariate in the analyses.
This study is expected to contribute evidence regarding whether a virtual assistant-based exercise program represents a viable, effective, and acceptable alternative to conventional program delivery models for promoting active and healthy aging in community-dwelling older adults.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Nonrandomized controlled clinical trial comparing a virtual assistant-guided home-based exercise program with the existing municipal program Enguera se saludable to evaluate adherence and health outcomes in older adults.
| Arm | Type | Receives |
|---|---|---|
| Bot Group | Experimental | Procedure: Exercise programParticipants in this group will complete a 12-week home-based exercise program delivered and monitored by a virtual assistant (BOT). The program consists of 60-minute sessions, three times per week, including guided instructions, automated reminders, and adherence tracking. The BOT provides real-time session support and records participation throughout the intervention. |
| Enguera program Group | Active comparator | Procedure: Exercise programParticipants in this group are individuals already enrolled in the municipal program "Enguera se saludable", which offers a face-to-face, instructor-led exercise program of the same duration and frequency (60 minutes, three times per week for 12 weeks). Attendance is recorded routinely by program instructors and will be used to assess adherence. |
Who may qualify
- Ages
- 59 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 60 years or older.
- Community-dwelling individuals capable of participating in an exercise program.
- Ability to complete 60-minute exercise sessions, three times per week during the 12-week intervention.
- Experimental group (BOT Group): Participants willing to use a smartphone/tablet and interact with the virtual assistant.
- Control group (Municipal Exercise Group): Individuals already enrolled in the municipal program Enguera se saludable.
Key exclusion criteria (7 listed)
- Medical contraindications to physical exercise, as determined by clinical judgment (e.g., uncontrolled cardiovascular, respiratory, or metabolic conditions).
- Severe cognitive impairment or neurological conditions that limit the ability to follow instructions or safely perform the exercise program.
- Severe mobility limitations preventing participation in structured exercise (e.g., inability to walk independently with or without aid).
- Acute musculoskeletal injuries or recent surgeries that contraindicate exercise participation.
- Individuals currently participating in another structured exercise program that would interfere with the study interventions (other than Enguera se saludable for the control group).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programBOT Group: Home-based exercise program delivered through a virtual assistant for 12 weeks (60 minutes, three times per week), including guided instructions and adherence monitoring. Enguera Exercise Group: Face-to-face, instructor-led exercise sessions from the Enguera se saludable program, with the same frequency and duration (60 minutes, three times per week for 12 weeks). | Procedure or surgery | Bot Group, Enguera program Group |
Primary outcome
Exercise Adherence (% of prescribed sessions completed)
Time frame: End of the 12-week intervention.
Exercise adherence will be defined as the percentage of prescribed exercise sessions completed during the 12-week intervention. A single adherence value will be calculated for each participant as: \text{Adherence (%) = (Sessions completed / Sessions prescribed) × 100} Measurement method: Virtual Assistant/BOT Group: Adherence will be recorded automatically by the virtual assistant (BOT), which logs session completion in real time. Municipal Exercise Group: Adherence will be calculated from attendance records routinely collected in the Enguera se saludable municipal program, using the same formula (completed / prescribed × 100). Although adherence is obtained from different data sources, the measurement itself is identical in both groups, expressed as a percentage (%).
4 secondary outcomes
Physical performance assessed by the Short Physical Performance Battery (SPPB)
Time frame: Baseline and 12 weeks.
Accelerometry-Based Physical Activity (Moderate-to-Vigorous Activity Levels)
Time frame: Baseline and 12 weeks
Risk of falls measured by the FallSkip® system (Fall Risk Index, 0-100)
Time frame: Baseline and 12 weeks
User experience and usability of the virtual assistant measured with a Visual Analog Scale (VAS)
Time frame: 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CARMEN GARCÍA GOMARIZ, Phd principal investigator
UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Older Adult and Exercise, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CARMEN GARCÍA GOMARIZ, Phd (963983853, Carmen.garcia-gomariz@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Adherence (% of prescribed sessions completed) (time frame: End of the 12-week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.